510(k) K173359 ยท GEX Powered Laser Surgical Instrument
Fractional CO2 Surgical Laser System
| Applicant | Ami, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Jul 5, 2018 |
| Received | Oct 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173359
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.